We have over 30 years’ experience working with a range of medical device clients from start-ups to global multi-nationals on a wide range of projects.
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Quality Management System (QMS), Technical File and Risk Management Documentation for the CE Mark.
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We will help you ensure your medical devices remain compliant and able to be sold in the EU.
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We will help you ensure your IVDs remain compliant and able to be sold within the EU.
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SGB Consulting help you through the audit process to gain ISO 27001:2022 certification.
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Allow us to professionally lead you through the audit process to a successful ISO 13485:2016 certification.
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We supply Software Quality Assurance and Regulatory Advice to ensure CE Mark or FDA approval.
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Helping your company gain access and compliance in all the main markets for medical devices globally.
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We support foreign device manufacturers to fully comply with the post-Brexit requirements.
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informed about the latest updates and requirements regarding EUDAMED to ensure compliance.
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As a one-stop-shop for our customers, our services cover everything required for continued compliance.
Read moreWe can help you gain access to a wide range of global medical device markets including, but not limited to the following:
